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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Adverse Event Study


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General
Application Number P030016 / PAS001
Current Plan Approved 06/08/2012
Study Name OSB Lead-Adverse Event Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective Registry with patients reporting outcomes
Study Population Description The device is indicated for adults 21-45 years of age:to correct myopia ranging from -3.0 diopters to < - 15.0 diopters with less, than or equal to 2.5 diopters of astigmatism at the spectacle, plane; * to reduce myopia ranging from greater than -15.0 diopters to - 20.0, diopters with less than or equal to 2.5 diopters of astigmatism at tile spectacle plane; and, with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. The Study includes subjects who are 21-45 years of age with myopia of -3.0 diopters to -20 diopters.
Sample Size 3,000 eyes will be enrolled

2,000 treated eyes needed with 5-year data

Data Collection Corneal edema, cataract, chronic uveitis, glaucoma, retinal detachment, second surgery, and other complications assessed by patient questionnaire
Follow-up Visits and Length of Follow-up 6, 12, 18, 24, 36,48, and 60 months after implantation
Final Study Results
Interim Safety Information Corneal edmea 0.14%, cataract 1.33%, inflammation 0.21%, high IOP 0.76%, RD 0.21%, reposition IOL 0.97%


OSB Lead-Adverse Event Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 03/30/2007 03/30/2007 On Time
2 year report 05/30/2009 04/30/2009 On Time
3 year report 12/22/2009 04/29/2010 Overdue/Received
4 year report 12/22/2010 03/07/2011 Overdue/Received
report 07/31/2012 07/27/2012 On Time
annual report 07/31/2013 08/01/2013 Overdue/Received
annual report 08/01/2014 08/01/2014 On Time
annual report 07/31/2015 07/31/2015 On Time
yearly report 07/31/2016 07/27/2016 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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